Fecal microbiota transplantation for treating gastrointestinal graft-versus-host disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the use of fecal microbiota transplantation (FMT) to treat patients suffering from gastrointestinal acute graft-versus-host disease (GI-aGvHD) following allogeneic hematopoietic stem cell transplantation (ASCT). The study focuses on patients with steroid-refractory GI-aGvHD who exhibit reduced bacterial diversity in their stool microbiota. FMT involves the infusion of healthy donor stool into the patient's gastrointestinal tract via colonoscopy, aiming to restore a healthy microbiome and alleviate symptoms of GI-aGvHD. The trial is designed to assess the efficacy and safety of this intervention in improving patient outcomes.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* first episode of histologically confirmed, steroid-refractory GI-aGvHD
* reduced bacterial diversity in the patient´s stool microbiota evidenced by 16s-rDNA measurement
* eligibility for repeated colonoscopic procedures
* informed consent

Exclusion Criteria:

* complications during a previous colonoscopy
* recurrent episode of GI-aGvHD
* lacking cardiopulmonary fitness for repeated colonoscopic procedures
* septic infection
* acute extraintestinal organ failure (excluding bone marrow)
* mechanical ileus

Where it's running

• Division of Gastroenterology and Hepatology, Department of Internal Medicine, Medical University of Graz
  Graz, Styria, Austria Recruiting

Study contacts

• Principal investigator: Peter Prof. Dr. Neumeister — Department of Internal Medicine, Division of Hematology, Medical University of Graz
• Study coordinator: Walter - DDr. Spindelboeck
• Email: walter.spindelboeck@medunigraz.at
• Phone: 0043 316 385 30195

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.